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A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer

NCT01946204 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1207

Last updated 2026-05-11

Study results available
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Summary

The purpose of this study is to evaluate the efficacy and safety of apalutamide in adult men with high-risk non-metastatic castration-resistant prostate cancer.

Conditions

  • Prostatic Neoplasms

Interventions

DRUG

Apalutamide

240 mg tablets administered by mouth on a continuous once daily dosing regimen

DRUG

Placebo

Matched placebo tablets administered by mouth on a continuous once daily dosing regimen

Sponsors & Collaborators

  • Aragon Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Aragon Pharmaceuticals, Inc. Clinical Trial · Aragon Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-14
Primary Completion
2017-05-19
Completion
2027-12-31

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Hungary
  • Israel
  • Japan
  • Netherlands
  • New Zealand
  • Norway
  • Poland
  • Romania
  • Russia
  • Slovakia
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01946204 on ClinicalTrials.gov